Open Trial of Family-Based Treatment for Anorexia Nervosa | NCT00417521

Studies
Open Trial of Family-Based Treatment for Anorexia Nervosa

NCT00417521

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Sep 26, 2013Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Anorexia Nervosa

Interventions

Family-Based Treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2004

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Dec 28, 2006

First Submission Date that Met QC Criteria

Dec 28, 2006

First Posted Date

Jan 1, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2013

Last Update Posted Date

Sep 26, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa

Detailed Description

This open trial seeks to investigate the feasibility and effectiveness of delivering a newly manualized family-based treatment for adolescents with anorexia nervosa at a site beyond the treatment's origin. Adolescents ages 12-17 with anorexia nervosa or subthreshold anorexia nervosa were treated with up to one year of this approach.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Label	Type	Description	Intervention Names
Family therapy	Experimental		Behavioral: Family-Based Treatment

Name	Type	Description	Arm Group Labels	Other Names
Family-Based Treatment	Behavioral		Family therapy

Measure	Description	Time Frame
weight		end of treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 12-17
Diagnosis of full or subthreshold anorexia nervosa
At least one parent or guardian willing to participate in treatment

Exclusion Criteria:

Bipolar Disorder, Psychotic Disorder, Substance Dependence
Mental Retardation
Acute suicidal risk
Acute or unstable, poorly controlled chronic medical illness
Weight below 75% ideal body weight

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jennifer Jones	New York State Psychiatric Institute	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000856	Anorexia Nervosa
D000855	Anorexia
D001068	Feeding and Eating Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided